Quest Diagnostics

Director, Quality (Clinical Laboratory)

Quest Diagnostics • $110K — $130K *
Cleveland, OH 44103In-Person
Healthcare
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 10+ years of experience in a Clinical Laboratory setting
  • 5+ years in leadership and management roles
  • 3+ years in a Regulatory Environment with knowledge of state and federal requirements
  • Demonstrated expertise in Quality Improvement
  • Excellent verbal and written communication skills
  • Ability to work independently and collaboratively across teams
  • Bachelor’s Degree required; Master’s or PhD in Life Sciences or MBA preferred

Responsibilities

  • Ensure compliance with federal and state laboratory testing regulations
  • Oversee Quality Assurance operations and related programs
  • Manage the Quality Improvement System, including CAPA and Root Cause Analysis
  • Direct internal and external audits for compliance with industry standards
  • Validate new tests and ensure quality in Laboratory Developed Tests
  • Coordinate development of scorecard metrics and business unit goals
  • Prepare Management Review documents and ensure timely responses to customer feedback

Benefits

  • Participation in a leadership team impacting business operations
  • Opportunities for professional development in regulatory compliance
  • Involvement in significant quality improvement initiatives
  • Potential for cross-functional collaboration impacting overall business strategy
  • Access to a dynamic work environment with direct impact on quality assurance standards
Full Job Description
JOB DESCRIPTION

The Director, Quality is directly responsible for coordinating and directing all functions of Quality Assurance and theCA CLS Limited License Training Program. This position assumes responsibility for ensuring that all technical and business requirements for laboratory testing are in place and maintained through theQualityManagementSystem.

The Director, Quality sitsasamemberoftheBusinessUnit'sLeadershipTeamand is responsible for participating in all associated communications, planning and coordination activities and works closely with Managing Director-Operations/Business/Staffing.


JOB RESPONSIBILITIES
  • Ensurecompliancewithfederalandstatelawsandregulationsconcerninglaboratorytesting procedures and results.
  • OverseeandmanageoperationsforQualityAssurance,theQualityImprovementSystem, State Licensure, and the CA CLS Limited License Training Program.
  • ManagetheQualityImprovementSystem,whichincludes Root Cause Analysis,CorrectiveandPreventativeAction (CAPA) and Annual Quality Improvement Plans.
  • DirectinternalandexternalauditsrelatedtoISO,CAP, StateLaboratoryAgenciesand Clinical Trials.
  • Ensure quality of new test validations, including Laboratory Developed Tests
  • Responsible for preparedness, the audit process, and follow-up activities.
  • Ensure an effective program of Document Control is in place.
  • Coordinate and approve development of scorecard metrics and goals for Business Unit.
  • Prepare and maintain Management Review document
  • Coordinate corporate quality and Customer directives with local procedures.
  • AssureaccurateandtimelyresponsetoCustomerFeedbackanddemonstratecontinuous improvement to Customer Satisfaction Survey Scores.
  • EnsureTrainingandcompetencyrequirementsaredefinedandachievedattheBusiness Unit.
  • Responsible for Business Unit's compliance with Clinical Trials Service Level Agreement.
  • Identify and relate the quality control, quality management requirements of Quest Diagnostics Inc. and the State, Federal and other agencies to department directors, managers,andsupervisorstoensurethattheserequirementsareimplementedandauditd
  • for compliance.
  • Advise the appropriate supervisor, managers, or technical director, if and when requirements are not met. Inform the Medical Director of such deviations.
  • Advise the Medical Director regarding the quality status of the laboratory on a regularly scheduled basis.
  • Manage off-site and in-house inspections, as required.
  • Assemble and maintain procedures of Quality Assurance Department.
  • Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.
  • Perform other related duties are requested by the Medical Director, and/or Managing Director.

JOB QUALIFICATIONS

Required Work Experience:

  • 10+ years in a Clinical Laboratory setting.
  • 5+ years of demonstrated leadership and management responsibilities.
  • 3+ years of experience in a Regulatory Environment or demonstrated knowledge in state and federal regulatory requirements.

Knowledge:

  • Demonstrated knowledge in state and federal regulatory requirements.

Skills:

  • Demonstrated skills and training in Quality Improvement.
  • Excellent communication skills, verbal and written.
  • Ability to work without direct supervision.

  • Demonstrated ability to collaborate effectively across teams and functions.

People Leader Responsibility:

  • Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.
  • 4 Direct reports and 3 Indirect Reports

Education

  • Bachelors Degree (Required)
  • Masters Degree or PhD in Life Sciences or MBA highly desirable. (Preferred)

About Quest Diagnostics

Celera is a healthcare business that uses knowledge of human variability to provide new tests and services to personalize disease management. Their Products business develops and manufactures molecular diagnostic products that are used by hospitals and other clinical laboratories to detect, characterize, monitor and select treatment for disease. They have a distribution agreement with Abbott, through which they develop and commercialize a wide range of molecular diagnostic products, with Abbott serving as the distribution partner.

Quest Diagnostics Careers

Joining Quest Diagnostics means becoming part of a team committed to everyday excellence and innovation in health. As a leading provider of diagnostic insights, Quest Diagnostics offers unparalleled job opportunities in the medical and scientific sectors, making it an ideal place for professionals seeking growth and development in their careers.

Work You’ll Do

At Quest Diagnostics, you will contribute to a culture that values integrity and accountability, where your work significantly impacts patient health and community well-being. Our diverse team of professionals leverages cutting-edge technology and data to lead advancements in diagnostics and healthcare solutions.

Explore Career Opportunities

Whether you're looking for a position in the lab, a leadership role, or a support function, Quest Diagnostics provides a breadth of opportunities. Our commitment to professional growth includes robust training programs and opportunities for advancement, ensuring that every employee can thrive professionally.

Innovate with Us

Join a team where innovation is at the heart of what we do. At Quest Diagnostics, your skills in science, technology, and beyond can help drive transformation in healthcare services. Our collaborative environment encourages creativity and out-of-the-box thinking to improve patient outcomes and streamline processes.

Internship and Employment Opportunities

Start your career path with Quest Diagnostics through our internship programs or full-time employment opportunities. We are committed to hiring talented individuals who are passionate about building a rewarding career in healthcare. Our internships provide a solid foundation in industry-specific skills and networking opportunities, setting the stage for a successful career.

Benefits and Culture

Quest Diagnostics is dedicated to fostering a workplace where diversity and inclusion are embedded in our DNA. From competitive benefits and wellness programs to diversity training and flexible work arrangements, we ensure our employees have what they need to succeed both professionally and personally.

Leadership and Development

We believe in nurturing leadership skills at every level of the organization. Quest Diagnostics offers various leadership programs designed to help you grow as an influential professional. With continuous learning and development, you can expand your expertise and take on new challenges.

Join Our Team

Search open positions that match your skills and interests. At Quest Diagnostics, we look for driven, curious, and innovative team players who are ready to make a difference. Explore the many facets of our business, from scientific research to client services, and find where you can make your mark.

Stay Connected

Keep up to date with career tips, industry insights, and the latest innovations at Quest Diagnostics. Our careers blog offers valuable information to help you navigate your professional journey effectively.

Job Alert Emails

Customize your subscription to receive job alerts and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities waiting for you at Quest Diagnostics. At Quest Diagnostics, every role has an impact. Embark on your career journey with us and transform the landscape of healthcare through the power of insight.
Learn more about Quest Diagnostics
Size
40,000 employees
Market Cap
$17.8 billion
Industry
Healthcare
Net Income
$1.4 billion
Founded
1959
5 Year Trend
+7.5%
Revenue
$9.4 billion
NASDAQ
DGX
* Ladders Estimates

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